A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)
NCT ID: NCT06063317
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2023-10-02
2029-05-31
Brief Summary
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Detailed Description
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Subjects eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy.
All enrolled monotherapy subjects will be treated with CF33-CD19 on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle thereafter. Subjects treated with the combination regimen will receive CF33-CD19 on Days 1 and 15 of each 28-day cycle. In addition, they will receive blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23 of each cycle.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CF33-CD19 IV Administration in Combination with Blinatumomab
CF33-CD19 IV Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28 day cycle.
Blinatumomab
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.
CF33-CD19 IT Administration in Combination with Blinatumomab and Hydroxyurea
CF33-CD19 IT Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28 day cycle.
Blinatumomab
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.
Hydroxyurea
Hydroxyurea will be orally administered daily.
CF33-CD19 IV Administration in Combination with Blinatumomab and Hydroxyurea
CF33-CD19 IV Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28 day cycle.
Blinatumomab
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.
Hydroxyurea
Hydroxyurea will be orally administered daily.
CF33-CD19 IV Administration Monotherapy
CF33-CD19 IV Monotherapy
Safety Run-In Phase: CF33-CD19 will be administered intravenously on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.
CF33-CD19 IT Administration in Combination with Blinatumomab
CF33-CD19 IT Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28 day cycle.
Blinatumomab
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.
CF33-CD19 IT Administration Monotherapy
CF33-CD19 IT Monotherapy
Safety Run-In Phase: CF33-CD19 will be administered intratumorally on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.
Interventions
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CF33-CD19 IT Monotherapy
Safety Run-In Phase: CF33-CD19 will be administered intratumorally on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.
CF33-CD19 IV Monotherapy
Safety Run-In Phase: CF33-CD19 will be administered intravenously on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.
CF33-CD19 IT Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28 day cycle.
CF33-CD19 IV Combination
Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28 day cycle.
Blinatumomab
Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.
Hydroxyurea
Hydroxyurea will be orally administered daily.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years old on the date of consent.
3. Life expectancy of at least 3 months.
4. Any histologically or cytologically confirmed advanced or metastatic solid tumor with documented radiological progression per RECIST v1.1. Eligible subjects must have received at least two prior lines of approved therapies, including targeted therapies, for which they are eligible and failed or relapsed on or after that treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
6. At least one measurable lesion as defined by RECIST v1.1 criteria.
7. Adequate renal function.
8. Adequate hepatic function.
9. Adequate hematologic function.
10. Willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
2. Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
3. Any radiation within 2 weeks of start of study treatment.
4. Active autoimmune disease.
5. Current or history of severe skin disease with open wounds.
6. History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
7. History of pancreatitis.
8. Prior allogeneic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state.
9. Medical history of central nervous system (CNS) metastases unless the subject has completed definitive treatment for the CNS lesions with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) and are neurologically stable, asymptomatic, and off corticosteroids for at least 2 months prior to first dose.
10. History of documented congestive heart failure (New York Heart Association \[NYHA\] class II - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias.
11. Bleeding diathesis due to underlying medical condition or ongoing anticoagulation medication.
12. History or presence of clinically relevant CNS pathology, or any other CNS disability judged by the Investigator to be clinically significant and precluding informed consent or participation in the study.
13. Active infection requiring systemic treatment.
18 Years
ALL
No
Sponsors
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Imugene Limited
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern
Chicago, Illinois, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Imugene Limited (ASX: IMU) is a publicly-listed Australian biotechnology company developing cancer immunotherapies.
Other Identifiers
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CF33-CD19-101
Identifier Type: -
Identifier Source: org_study_id